SOPHIA ANTIPOLIS, France, November 24 /PRNewswire-FirstCall/ -- NicOx
S.A. (NYSE Euronext Paris: COX) today announced that the third pivotal phase
3 study for naproxcinod in patients with OA of the hip showed a highly
statistically significant result (p<0.001) on all three co-primary efficacy
endpoints of the trial. Naproxcinod 750 mg bid showed the same
gastrointestinal (GI) adverse event rate and a similar blood pressure profile
to placebo. Naproxcinod is the most advanced compound in a novel class of
anti-inflammatory agents known as Cyclooxygenase-Inhibiting Nitric Oxide
Donators (CINODs).

Following the positive results from the 301 and 302 studies in patients
with OA of the knee, 303 represents the third phase 3 study for naproxcinod
to achieve p<0.001 on all three co-primary efficacy endpoints. The 303 study
is also the final pivotal trial that NicOx plans to include in the submission
of a New Drug Application (NDA) to the US Food and Drug Administration (FDA)
in mid-2009.

"This study has demonstrated clear-cut efficacy for naproxcinod 750 mg
bid in hip OA, in addition to providing reassuring blood pressure and safety
data," said Thomas J. Schnitzer, MD, PhD, Professor of Medicine at
Northwestern University Feinberg School of Medicine, who advised NicOx on the
design and analysis of the trial. "Meeting the primary endpoints of this
study is a significant achievement, considering the difficultly in
controlling the symptoms of hip OA patients. Few studies with other
anti-inflammatory agents have focused only on people with hip OA, in part
because of the increased difficulty in demonstrating efficacy in this
population compared to knee OA. Additionally, the fact that the blood
pressure data for naproxcinod and placebo were similar at all time points is
also encouraging, as there is a definite need for new anti-inflammatory
agents that do not increase blood pressure."

The blood pressure data for naproxcinod 750 mg bid were consistent with
those obtained in the 301 and 302 studies. Blood pressure was measured using
standardized and controlled office blood pressure measurements (OBPM) at
baseline and at weeks 2, 6 and 13 (see NOTE). At all time points, the
patients treated with naproxcinod 750 mg bid showed a very similar blood
pressure profile to those on placebo. In addition, naproxcinod 750 mg bid
showed a clear reduction in systolic and diastolic blood pressure (SBP and
DBP) compared to naproxen 500 mg bid at all time points. No stand alone
statistical analysis of the blood pressure data from the 303 study was
pre-specified.

As planned, NicOx will pool the blood pressure data from the three phase
3 studies (301, 302 and 303) according to a prospectively designed protocol
that has been submitted to the FDA. The Company will disclose the top-line
results of the pre-specified statistical analysis on the pooled data in the
coming weeks.

Naproxcinod and placebo show the same gastrointestinal (GI) adverse event
rate

Naproxcinod 750 mg bid showed good overall safety and tolerability. The
percentage of patients who experienced one or more GI adverse events was the
same for placebo and naproxcinod 750 mg bid at 15.5%, compared to 19.2% for
naproxen 500 mg bid. In terms of the percentage of patients who experienced
at least one adverse event overall, this was lower for naproxcinod 750 mg
than naproxen 500 mg bid. There was not a single serious cardiovascular or
serious GI adverse event in the naproxcinod arm during the 13 weeks of the
303 study, in contrast to the placebo and naproxen 500 mg bid arms.

Pascal Pfister MD, Chief Scientific Officer and Head of Research and
Development at NicOx, commented: "We believe these are extremely good
results, with naproxcinod demonstrating clear efficacy in this difficult type
of osteoarthritis patients and showing the same GI adverse event rate as
placebo. The blood pressure data are consistent with previous studies and we
are keenly awaiting the important results of the pre-defined statistical
analysis in the next few weeks, following the pooling of the 301, 302 and 303
blood pressure data. We are confident that these results will clearly
demonstrate naproxcinod's non-detrimental blood pressure profile, in contrast
to naproxen."

Design and results of the 303 study

The 303 study was a 13-week, double-blind, placebo and naproxen
controlled trial in patients with OA of the hip. 810 patients were enrolled
at 120 clinical centers in the United States, Canada and Europe. Eligible
patients had a diagnosis of primary osteoarthritis of the hip of at least
three months in duration and were randomized on a 2:2:1 basis to receive
naproxcinod 750 mg bid, placebo bid and naproxen 500 mg bid, respectively.

The three co-primary endpoints of the study compared the efficacy of
naproxcinod 750 mg bid to placebo, in terms of the mean change between
baseline and week 13 in the following scores: the WOMAC(TM) pain subscale,
the WOMAC(TM) function subscale and the subject's overall rating of disease
status. The results demonstrated that naproxcinod was superior to placebo
with high statistical significance (p<0.001) on all three of these co-primary
endpoints. These were the same endpoints as those used in the 301 and 302
phase 3 studies. No statistical comparison was made between naproxen 500 mg
bid and the other two arms on the efficacy endpoints, due to the 2:2:1
randomization in the study, although numerical data show that naproxcinod 750
mg bid behaved in a similar fashion to naproxen 500 mg bid on these efficacy
scores. NicOx entered into a full-service agreement for the conduct of the
303 study with Covance Inc., a global contract research organization (CRO).

NOTE: Office Blood Pressure Measurements (OBPMs) were performed by a
health care professional during a patient's visit to the treatment center
using a standard technique and equipment (i.e. a sphygmomanometer). OBPMs
were performed in the morning and the time between intake of study-drug and
measurement of OBPM was between 2 and 4 hours.

NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development and future
commercialization of investigational drugs for unmet medical needs. NicOx is
applying its proprietary nitric oxide-donating technology to develop an
internal portfolio of New Chemical Entities (NCEs) in the therapeutic areas
of inflammatory and cardio-metabolic disease.

Resources are focused on the development and pre-commercialization
activities for naproxcinod, a proprietary NCE and the first compound in the
Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of
anti-inflammatory agents for the treatment of the signs and symptoms of
osteoarthritis. Naproxcinod has completed three pivotal phase 3 studies with
positive results and the submission of a New Drug Application (NDA) to the US
Food and Drug Administration (FDA) is projected for mid-2009.

Beyond naproxcinod, NicOx has a pipeline containing multiple nitric
oxide-donating NCEs, which are in development internally and with partners,
including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent
and underserved diseases, such as atherosclerosis, hypertension, widespread
eye diseases and Chronic Obstructive Pulmonary Disease (COPD).

NicOx S.A. is headquartered in France and is listed on the NYSE Euronext
Paris (Compartment B: Mid Caps).

This press release contains certain forward-looking statements. Although
the Company believes its expectations are based on reasonable assumptions,
these forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ materially from
those anticipated in the forward-looking statements.

For a discussion of risks and uncertainties which could cause actual
results, financial condition, performance or achievements of NicOx S.A. to
differ from those contained in the forward-looking statements, please refer
to the Risk Factors ("Facteurs de Risque") section of the Document de
Reference filed with the AMF, which is available on the AMF website (
http://www.amf-france.org) or on NicOx S.A.'s website (http://www.nicox.com).

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